Recall record at a glance
| Official record | D-1464-2016 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Completed |
| Recalling firm | Stratus Pharmaceuticals Inc. |
| Report date | Aug 31, 2016 |
| Recall initiation date | May 26, 2016 |
| Quantity | a) 12,345 tubes; b) 8,578 tubes |
| Location | Miami, FL, United States |
Official product description
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Why the product was recalled
Crystallization; Complaints that cream appears to have crystallized
Distribution information
Nationwide and PR
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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